FDA Device recall Z-2148-2019
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction… by Olympus, citing there is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2148-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-01 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
Reason
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
Identifiers
| code_info | Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2148-2019%22
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